iteriumOld Saybrook: Iterum Therapeutics US Limited, of Dublin Ireland is expanding its space and commitment in Old Saybrook. The company has leased  9413 square feet, at 20 Research Parkway.  The company currently occupies only 2300 square feet in building, the US director is Corey Fishman.

Iterum is a clinical stage biotech business with offices in Chicago, Dublin, Ireland, and Old Saybrook, they recently raised $65 million in a Series B Financing to support a phase 3 clinical trial for a new anti-biotic to treat urinary tract infections.

The financing was led by new investor Arix Bioscience plc, and included Pivotal bioVenture Partners, Advent Life Sciences, Domain Associates and Bay City Capital. Acording to the company alll of its current investors (Frazier Healthcare Partners, Canaan Partners, Sofinnova Ventures and New Leaf Venture Partners) also participated in the round.

The owner of the complex is Mill Meadow Development, LLC. Kevin Geenty SIOR was the sole agent in this transaction. 

Screen Shot 2017 06 21 at 12.59.31 PMBy Mitchell Young

Shares of Alexion stock have taken off after being pummeled by concerns about executive turnover at the company and reports of “aggressive sales practices." The C-Suite changes were initiated by new CEO Ludwig Hantson.

The stock was trading at $96.95 as recently as May 26, down from a 52 week high of $145.

On June 14, after the announcement, filling the last of the company’s major management slots, with the hiring of Paul Clancy the day before, as the new CFO. [Clancy was previously with Biogen of Cambridge, MA, see New CFO and A Possible Looming Write Off - Help Boost Alexion Stock ] the stock made a 9% plus gain.

On June 14, Hantson purchased $1.16 million of the stock in the open market at approximately $116 per share. He was joined by Alexion board members Christopher Couglin who picked up $230,000 of shares and Alvin Parven who purchased $100,000 worth, both at around $116 per share as well.

melinta therapeutics large

By Mitchell Young

New Haven: The FDA has approved Melinta Therapeutics' Baxdela (delafloxacin), a fluoroquinolone antibiotic for the treatment of acute bacterial skin and skin structure infections (ABSSSI).

The company was founded by three of Yale University's leading scientist-researchers in 2000 as RIBx. The company first began work on the drug when it licensed it in 2006 under the then CEO Susan Froshauer, now CEO of Connecticut United for Resource Excellence [CURE]. 

The FDA also provided Qualified Infectious Disease Product (QIDP)Status which provides for an additional five-year period of market exclusivity for the approved purpose.

New CFO Paul Clancy brought a rise in the company's stock price with him.

By Mitchell Young

New Haven: Continued reports in the New Haven Register questioning the ethics and viability of Alexion have failed to halt a major rebound in the company’s stock. Alexion’s stock has increased by more than 22% percent [20 points] since Register reporting and short sellers questioned the company’s viability.

On June 13, Alexion named long-time Cambridge based Biogen Inc [Nasdaq: BIIB] CFO Paul Clancy, Chief Financial Officer of Alexion.

Biogen does nearly four times the revenue of Alexion and has double the market value. Wall Street analysts were very positive about the choice, and his hiring was apparently seen as evidence that there would not be “another shoe to drop” in terms of revelations about changes at the company.

Alexion stock had tanked amid media reports about the company’s “aggressive” marketing practices and a turn-over of executives that has followed the appointment of New CEO Ludwig Hantson. Hantson has replaced the core of Alexion’s management team, appointing four executives from his previous company, Baxalata [see Alexion CEO: Putting The New, Old Band Back Together].

Likewise, Clancy comes to Alexion after Biogen’s new CEO Michel Vounatsos has turned over his management team, amid complaints of lackluster performance. Clancy’s appointment created a 9% boost in Alexion’s stock.

Also on June 13, investment news site reported that Hantson floated the idea at the Golldman Sachs Healthcare Conference, that he is considering writing off the investment of one of the company's key drugs, Kanuma. The report said “he referred to the commercial results as near the bottom on biotech launches.

Kanuma is an enzyme replacement therapy for an ultra-rare inherited metabolic disorder, it was approved by the FDA at the end of 2015.

Sales of the drug were under $26 million for the full 2016 year. Alexion paid $8.4 billion in June of 2015 for Cambridge based Synageva BioPharma Corp. [Nasdaq:GEVA].

Alexion founder Leonard Bell and the CEO that initiated the acquisition justified the price at the time, saying the drug would eventually bring “$1 billion in sales.”

At the time of the closing of the acquisition, then Alexion’s CEO David Hallal, said, “as we complete this acquisition, the combination of our two companies provides us the exciting opportunity to build upon our collective strengths and talents to firmly establish Alexion as the global leader in serving patients with devastating and rare diseases, With Soliris, [Alexion’s flagship now $3 billion sales drug] and the anticipated approvals of Strensiq and Kanuma, Alexion is poised to have three innovative products serving patients with four severe diseases in 2015 while also advancing the deepest and broadest pipeline in our history.”

Stensiq was acquired in 2011 with the acquisition of Montreal based Enobia Pharma for under $1 billion and was also approved in 2015. Sales for this year [2017] are expected to exceed $200 million. Previous estimates for the two drugs were $1.5 -$2 billion annually.

 John Orloff, New Alexion R&D Head did seven Years at Yale Med School

By Mitchell Young

Key Executive Hires From Hantson's Previous Company, Baxalta

New Haven: What new Alexion [ Nasdaq{: ALXN ]CEO  Ludwig Hantson has in mind in his C Suite makeover has gotten a little more clear. In Early May, the company announced the departure of four key executives, including Martin Mackay, EVP and the head of R&D for the company who will “retire” this year. McKay joined Alexion in 2013 and will be replaced by John Orloff, M.D.

Orloff has most recently been head of R&D at Novelion [Nasdaq: NVLN] a small $175 million market cap rare disease biotech headquartered in Vancouver, B.C. with operations in Cambridge Mass as well.

Before then, Orloff was global head of R&D and CSO [Chief Science Officer] at Baxalta, where he worked for then CEO Hantson.  


melinta therapeutics largeBy Mitchell Young

Menarini.svg New Haven: In less than three weeks on June 19, the executives, investors, pharmaceutical company partners and the Yale University researchers that founded Melinta Therapeutics are expecting to learn whether the seventeen years of efforts have paid off with the anticipated approval by the FDA of Delafloxacin, a drug to treat serious infections.

Delafloxacin, [Baxdela in the US] is for “hospital-treated skin infections, known as acute bacterial skin and skin structure infections (ABSSSI) including treatment for methicillin-resistant Staphylococcus aureus [MRSA], a major cause of hospital-treated skin infections.”

In March, privately held Melinta and the Menarini Group, a $3.5 billion in revenue Florence, Italy based, privately owned biopharmaceutical group, signed a development and commercialization agreement for Delafloxacin.

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Jackson Labs, Farmington, Connecticut

By Mitchell Young

Farmington: The controversial $290 million investment promoted by Governor Dannel Malloy in a major Genomics research facility by Jackson Labs [Jax], is looking pretty good for now. The facility opened in 2014 with an initial employment of 30 scientists and administrators.